Browse hierarchy: [Dental (DE)](/submissions/DE) → [Subpart D — Prosthetic Devices](/submissions/DE/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 872.3260](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/872.3260) → PHR — Diammine Silver Fluoride Dental Hypersensitivity Varnish

# PHR · Diammine Silver Fluoride Dental Hypersensitivity Varnish

_Dental · 21 CFR 872.3260 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/PHR

## Overview

- **Product Code:** PHR
- **Device Name:** Diammine Silver Fluoride Dental Hypersensitivity Varnish
- **Regulation:** [21 CFR 872.3260](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/872.3260)
- **Device Class:** 2
- **Review Panel:** [Dental](/submissions/DE)
- **3rd-party reviewable:** yes

## Identification

Cavity varnish is a device that consists of a compound intended to coat a prepared cavity of a tooth before insertion of restorative materials. The device is intended to prevent penetration of restorative materials, such as amalgam, into the dentinal tissue.

## Classification Rationale

Class II (special controls). The device, when it is an external cleaning solution, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.

## Special Controls

*Classification.* Class II (special controls). The device, when it is an external cleaning solution, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.

## Recent Cleared Devices (8 of 8)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K250222](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/PHR/K250222.md) | SDF Pro | Belport Company, Inc., Gingi-Pak | May 7, 2025 | SESE |
| [K241041](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/PHR/K241041.md) | Silver Fluoride Hypersensitivity Varnish | Young Dental Manufacturing Co. 1, LLC | Feb 28, 2025 | SESE |
| [K240059](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/PHR/K240059.md) | FAgamin® | Tedequim Srl | May 16, 2024 | SESE |
| [K240619](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/PHR/K240619.md) | e-SDF | Kids-E-Dental Llp | Mar 6, 2024 | SESE |
| [K222459](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/PHR/K222459.md) | Centrix FluoroSilver Silver Diamine Fluoride 38% | Centrix, Inc. | Oct 27, 2023 | SESE |
| [K222323](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/PHR/K222323.md) | Black Diamond | Elevate Oral Care, LLC | Jun 23, 2023 | SESE |
| [K172047](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/PHR/K172047.md) | Riva Star | Sdi Limited | Apr 11, 2018 | SESE |
| [K102973](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/PHR/K102973.md) | SILVER DENTAL ARREST | Cooley Consulting, Inc. | Jul 31, 2014 | SESE |

## Top Applicants

- Belport Company, Inc., Gingi-Pak — 1 clearance
- Centrix, Inc. — 1 clearance
- Cooley Consulting, Inc. — 1 clearance
- Elevate Oral Care, LLC — 1 clearance
- Kids-E-Dental Llp — 1 clearance

---

**Source:** [https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/PHR](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/PHR)

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